In the News: Oncology - May 2016

Atezolizumab injection (Tecentriq) has been approved by the US Food and Drug Administration for patients with locally advanced or metastatic urothelial carcinoma with disease progression after or ≤12 months of receiving platinum-containing chemotherapy. The recommended dosage of the drug, which is programmed death-ligand 1 blocking antibody, is 1200 mg administered intravenously every 3 weeks until disease progression or unacceptable toxicity.

The US Food and Drug Administration has approved nivolumab (Opdivo) for patients with classical Hodgkin Lymphoma that has progressed or relapsed following autologous hematopoietic stem cell transplantation and post-transplant brentuximab vedotin, according to an announcement by the agency. Notably, the intravenous drug was granted accelerated approval, and Breakthrough Therapy Designation.

Lenvatinib capsules (Lenvima) have been approved in combination with everolimus in patients with advanced renal cell carcinoma who have had 1 previous anti-angiogenic therapy, according to an announcement by the US Food and Drug Administration. The combination has demonstrated greater progression-free and overall survival rates, compared with lenvatinib monotherapy.

Venetoclax (Venclexta) has been approved by the US Food and Drug Administration (FDA) for daily use in patients with chronic lymphocytic leukemia (CLL) who have 17p deletion, and had ≥1 prior therapies, according to an announcement by the agency. This drug is the first treatment that targets the B-cell lymphoma 2 protein, which is overexpressed in many patients with CLL.

Defibrotide sodium (Defitelio) is now US Food and Drug Administration (FDA)-approved for children and adult patients with hepatic veno-occlusive disease (VOD) with added kidney or lung abnormalities following hematopoietic stem cell transplantation (HSCT). This drug is the first to be approved for patients with severe hepatic VOD.

Immediate-release opioid analgesics will now require boxed warnings regarding the serious risks for abuse, addiction, overdose, neonatal opioid withdrawal syndrome (NOWS), and death associated with the drugs, according to an announcement by the US Food and Drug Administration (FDA).